BEUDAMED
    FDA Recall Terminated

    Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.

    Recall: Z-0479-2009 · Initiated September 8, 2008

    Recall

    Recall Number
    Z-0479-2009
    Event Number
    49557
    Firm
    OraSure Technologies, Inc.
    FEI Number
    2528909
    Product Code
    LDJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 8, 2008
    Posted
    December 23, 2008
    Terminated
    May 5, 2009
    Address
    1745 Eaton Ave, Bethlehem, PA, 18018-1769

    Description

    Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit.

    Reason

    Results, false-positive test: low % displacement result of 36.0% (spec 39-60%). For further information, please contact the firm at 610-882-1820.

    Action

    The recalling firm issued a letter entitled "URGENT PRODUCT RECALL NOTICE" dated 9/8/08 to their customers to inform them of the problem and the need to return the product.

    Distribution

    Worldwide Distribution --- USA including states of AZ, CA, CT, DE, FL, GA, ID, KS, KY, MA, MD, MI, NC, NH, NV, NY, PA, VA, and WY, and countries of United Kingdom, Italy, Germany, and Canada.

    Quantity

    2198 units